FDA 510(k)

Rüsch Latex Gold Foley Catheter

K番号: K232469 · 2024-08-01

決定日2024-08-01

製品コードEZL

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定Substantially Equivalent

医療機器の概要

Rüsch Latex Gold Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K232469. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Rüsch Latex Gold Foley Catheter?

Rüsch Latex Gold Foley Catheter is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K232469.

When did Rüsch Latex Gold Foley Catheter receive FDA 510(k) clearance?

Rüsch Latex Gold Foley Catheter received FDA 510(k) clearance on 2024-08-01, under 510(k) number K232469.

Who is the listed applicant for Rüsch Latex Gold Foley Catheter?

The FDA 510(k) record lists Teleflexmedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rüsch Latex Gold Foley Catheter?

The FDA product code for Rüsch Latex Gold Foley Catheter is EZL.

申請者としてTeleflexmedical, Inc.を記載するその他の記録

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